IRB Connection HSO Newsletter

 
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2024

February

  • How does the University of Iowa prepare for AAHRPP Accreditation?
  • Recordings Available for IRB Efficiency Initiative, January 2024 Roll Out
  • UI IRB SOP and Researcher Guide and Policy Changes
  • Short Form Consent Process: Witness Signature is Required
  • Optimizing Registration and Results Reporting on ClinicalTrials.gov
  • FDA Guidance Updates
  • Promoting Global Clinical Research in Children
  • In the News

January

  • What is AAHRPP Accreditation?
  • Certificates of Confidentiality: What are They and Why do They Matter?
  • Two Recent FDA Guidance Documents
  • Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs
  • Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
  • Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
  • Division of Sponsored Programs Rebroadcast: NDA Winter Data Submission Cycle
  • Division of Sponsored Programs Rebroadcast: NIH Policy for Data Management and Sharing
  • Recent IRB Presentation Recording Available
  • In the News

2023

December

  • Holiday Wishes
  • OVPR Research Recruitment Survey
  • Transparency In Clinical Trials and The Role of FDA Oversight
  • Human Subjects Research in the UIHC: Not Just IRB Compliance
  • HawkIRB User Interface
  • Recent IRB Presentation Recordings Available
  • In the News

November

  • Best Practices for Research Collaboration and Data Sharing
  • Herky Hint: Data Sharing and Security
  • Informed Consent Tips
  • eConsent Process and Checklists
  • Tabling a Form Submission
  • Medical Ethics Advisor Newsletter, October 2023
  • In the News

October

  • Herky Hint: HawkIRB Automatically Assigns Delegates to all New Projects
  • Presentation Recap: Unlocking the Mystery of IRB Compliance Monitoring
  • Recent Presentation Recordings
  • Medical Ethics Advisor Newsletter, September 2023
  • In the News

September

  • Research Navigation Tool – for faculty and research scientists
  • Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
  • CITI Training at Previous Institution
  • External IRB Q&A: Non-UI Team Members
  • General Data Protection Regulation (GDPR) May Affect Your Research Plan
  • ClinicalTrials.gov Webinar Series (hosted by the Food and Drug Administration)
  • Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
  • An Invitation - UI Research Services Fair (October 12, 2023)
  • Medical Ethics Advisor Newsletter, August 2023
  • In the News

August

  • Course-Related Student Projects: The Exception to the Rule
  • Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs
  • Best practices: Studies Involving LGBTQIA+ Persons
  • Informed Consent – New Food and Drug Administration (FDA) Guidance
  • Medical Ethics Advisor Newsletter, July 2023
  • In the News

July

  • IRB Member Recruitment: Seeking Help from the UI Research Community
  • DSP Rebroadcast: UI Research Data Policy and American Heart Association Open Data Policy
  • Herky Hint: Acceptable Justifications for Waiver of Documentation of Consent
  • Gathering Identifiers for Research Subject Compensation
  • Give It to ‘Em Straight: Health Literacy in Clinical Research
  • Recap: Hot Topics Lecture from July 12, 2023
  • Medical Ethics Advisor Newsletter, June 2023
  • In the News

June

  • Best Practices: Responding to IRB Meeting Minutes
  • Herky Hint: Protocol Amendments
  • Do You Want to Build a Snow(ball sample)?
  • Opening the Door: Accessibility and the IRB
  • NIH Rebroadcast: NIH Campus Interactive Virtual Tour
  • Medical Ethics Advisor Newsletter, May 2023
  • In the News

May

  • Good Application Initiative
  • Summer Student Research Internships
  • Project Closure Memo Now Available in HawkIRB
  • Herky Hint: Deception Requires a Waiver of Consent
  • Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
  • Recap of “The Single IRB Process: Navigating the Waters”
  • Recap of Casting the Net: Research Ethics in the Age of Social Media
  • Medical Ethics Advisor Newsletter, April 2023
  • In the News

April

  • Before a PI Leaves the UI: Transfer/Departure/Change of Status Forms and Procedures
  • Extra! Extra!: Offering Extra Credit as Compensation
  • HawkIRB Updates: Expanded Character Limits (ROC.5 and ROC.6)
  • Herky Hint: Assessing Capacity to Consent
  • Recap: March 2023 Hot Topics Lecture
  • Recap: ClinicalTrials.gov Reporting Requirements and Consequences of Noncompliance
  • Medical Ethics Advisor Newsletter, March 2023
  • In the News

March

  • Annual Disclosure of Outside Activities Due April 30
  • Herky Hint: Conflict of Interest—Don’t Guess!
  • Human Subjects Office Staffing
  • Trauma-informed Research Practices
  • Presentation Recap: FDA Site Inspection Guide—Your Best Tool for Preparing
  • The Top 10 Reasons Researchers Come to Office Hours and the Guidance We Give
  • Medical Ethics Advisor Newsletter, February 2023
  • In the News

February

  • Policy Reminder: Mass Email for Research Recruitment
  • Making it Plain: Meaningful Attachment Names in HawkIRB
  • Herky Hint: Editing and Stacking Attachments & Mac Instructions
  • NIH Grant Conference 2022 Presentation Recordings Now Available
  • Medical Ethics Advisor Newsletter, January 2023
  • In the News

January

  • Changes to HawkIRB Are Coming Soon!
  • Retrospective Record Reviews with Less Regulatory Burden
  • Make Effective Recruitment Plans – December 2022 Lecture Recap
  • Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs
  • Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
  • Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
  • DSP Rebroadcast: Preparing for 2023 Data Management and Sharing Policy
  • Medical Ethics Advisor Newsletter, December 2022
  • In the News

2022

December

  • Holiday Wishes
  • Hot Topics and Updates from the IRB and Human Research Protection Program
  • Herky Hint: How to get Clean, IRB-approved Documents
  • Medical Ethics Advisor Newsletter, October 2022
  • In the News

November

  • IRB Presentation Recap: Checklists and Guidance Documents Galore!
  • NIH-Funded Clinical Trials: Compliance with Reporting Results
  • From WIRB to WCG, Website Updates, and More
  • Food and Drug Administration Proposed Rule Change and Draft Guidance
  • Medical Ethics Advisor Newsletter, October 2022
  • In the News

October

  • The New Faculty/Staff Research Navigation Tool is here to help you!
  • What is your plan to reconsent subjects?
  • A Deeper Dive into the Research Process: Recordings of IRB/ICTS Lecture Series
  • Herky Hints: Watermark on Pregnancy Consent Documents
  • New FDA Draft Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children
  • Medical Ethics Advisor Newsletter, September 2022
  • In the News

September

  • Student PI Training Requirement
  • Herky Hints: Need documentation of what changed in a Modification form? No problem! Here is how to generate a copy of a form and an approval memo
  • Announcement: Faster Access to Federally Funded Research Results
  • Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
  • Medical Ethics Advisor Newsletter, August 2022
  • In the News

August

  • Course-Related Student Projects: The Exception to the Rule
  • Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
  • Increased Civil Monetary Penalties for ClinicalTrials.gov Record Noncompliance
  • Herky Hints: HawkIRB Filters: A Handy Tool for Research Team Members
  • Hot Topics and Updates from the IRB and Human Research Protection Program
  • Division of Sponsored Programs Rebroadcast: Implementation Details for NIH Data Management and Sharing Policy
  • Write Winning Grant Proposals Seminar and Workshop (2022-2023) – Registration open!
  • Medical Ethics Advisor Newsletter, July 2022
  • In the News

July

  • Continuing Medical Education Credit for Compliance Monitoring
  • The IRB Review Process: IRB/HSO/HRPP Improvements and Enhancements to Reduce Review Times
  • ClinicalTrials.gov - Educational Points and Best Practices
  • IRB ICON Course for Researchers – What’s in there, anyway?
  • View Recorded IRB presentations - IRB ICON Course for Researchers
  • NIH Webinars: Implementing the New Data Management and Sharing Policy
  • Medical Ethics Advisor Newsletter, June 2022
  • In the News

June

  • New Guidelines for Posting Informed Consent Documents for Federally Funded Research
  • HawkIRB Carousel Index: A Wealth of Information at Your Fingertips
  • Division of Sponsored Programs Rebroadcast: Revised Workflow Form for PI Departure, Grant Transfers, and VPR Request for Approval to serve as Adjunct, Visiting or Emeritus PI
  • Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
  • Medical Ethics Advisor Newsletter, May 2022
  • In the News

May

  • Hot Topics and Updates from the IRB and Human Research Protection Program
  • Good Cause Extension Submission Deadlines for Applicable Clinical Trials
  • NIH Releases New Policy – Data Management and Sharing
  • Exempt Research Application: Recorded HawkIRB Training
  • Write Winning Grant Proposals Seminar and Workshop (2022-2023) – Registration open!
  • Draft FDA Guidance: Diversity Plans to Improve Enrollment from Underrepresented Racial and Ethnic Populations
  • Upcoming Conference - Achieving Research Equity and Inclusion: Name It! Act On It! Change It!
  • Medical Ethics Advisor Newsletter, March and April 2022
  • In the News

April

  • Reminder: Pre-Grant Submission Survey for Single IRB Model
  • Annual Disclosure of Outside Activities Due Apr 30
  • The IRB Review Process—How Long is This Going to Take?
  • Going Abroad? Plan Ahead to Conduct Research Outside the U.S.
  • ClinicalTrials.gov Guidelines for Reporting Results – A Presentation to Simplify the Process
  • Presentation Overview: Single IRB of Record Review Model for Federally Funded, Multi-Site Research
  • Medical Ethics Advisor Newsletter, February 2022
  • In the News

March Announcements

  • University of Iowa Purchases System to Facilitate Clinical Trials Management
  • NIH FORMS-G Changes to be Reflected on Human Subjects Clinical Trials Form
  • Medical Ethics Advisor Newsletter, January 2022
  • In the News

January

  • Reminder: Pre-Grant Submission Survey for Single IRB Model
  • FAUCI & the Importance of Representation in Research: A Film Screening and Discussion
  • New Exempt Application Rollout
  • Protocol Outline Template
  • Medical Ethics Advisor Newsletter, December 2021
  • In the News

2021

December BONUS

  • Corporate Funded Clinical Trial F&A Rate Increase (***Rebroadcast***)
  • Holiday wishes from the HSO
  • Is there a recording of that IRB presentation I missed?
  • Herky Hints: HawkIRB Workflow
  • Medical Ethics Advisor Newsletter, October and November 2021
  • In the News

Early December

  • eRA Enhancements (***Rebroadcast from RAD: Research Administration Dispatch***)
  • WIRB / WCG Online Submission Platform Training December 8th
  • Recent Updates Made to the UI’s CITI Program
  • IRB Member Recruitment: Seeking IRB Community Members
  • ClinicalTrials.gov Late Results Reporting – Serious Noncompliance Resulted in FDA Warning Letters
  • In the News

October

  • Announcing Human Subjects Office (HSO) Education and Compliance Openings
  • Reverting to Virtual Presentations Only Beginning November 1
  • WIRB / WCG Online Submission Platform Training November 15th
  • Hot Topics & IRB/HRPP Updates
  • Research Billing Compliance: Ensuring a smooth road to success for your study
  • An Overview of the IRB Review Process
  • Locating Support and Training Materials for CT.gov
  • In the News

September

  • Four-part HawkIRB Training Series Recordings Now in ICON
  • The Student PI Training Requirement is Now in Effect
  • HawkIRB Enhancements
  • Reminder: Pre-Grant Submission Survey for Single IRB Model
  • Hot Topics & IRB/HRPP Updates
  • Social, Behavioral and Education Researchers: There is an IRB tool just for you!
  • Locating Support and Training Materials for CT.gov
  • IRB Advisor Newsletter, July 2021
  • In the News

July

  • HSO/IRB Return-to-Campus Notification
  • Incomplete HawkIRB Applications Will Now be Returned Without Review
  • Individual Research Results: To Share or Not to Share
  • HawkIRB Automated Feature: Creating a ClinicalTrials.gov record (Push to PRS)
  • IRB Advisor Newsletter, May and June 2021
  • In the News

June

  • Message from OVPR: Mask and Social Distancing Requirements Updated
  • New Training Requirement for Student Principal Investigators
  • Reminder: Pre-Grant Submission Survey for Single IRB Model
  • IRB Advisor Newsletter, April 2021
  • In the News

April

  • OVPR Announces Updated IRB Fee Information for FY2022
  • Getting on the Same Page: A Three-Part Presentation Series
  • Get to Know ClinicalTrials.gov (CT.Gov) Protocol Registration and Result System (PRS)
  • A New HSO/IRB Educational Resource
  • IRB Advisor Newsletter, March 2021
  • In the News

March

  • OHRP Announces Release of Research With Children Video
  • Annual Disclosure of Outside Activities Due April 30
  • Herky Hints: How to Edit and Attach Revised Documents to HawkIRB
  • IRB Advisor Newsletter, February 2021
  • In the News

February

  • IRB Membership: Regulatory Requirements and Rosters
  • What’s the Difference Between Human Subjects Protection and Good Clinical Practice Trainings?
  • External and Commercial IRB Q & A: What is the order of workflow for other committees when using a commercial external IRB?
  • Herky Hints: Selecting the Status of Your Funding in Section III
  • IRB Advisor Newsletter, January 2021
  • In the News

January

  • FDA Guidance on Complex Innovative Trial Design for Drugs and Biological Products
  • Announcement: Upcoming Lecture, “The Immortal Life of Henrietta Lacks”: A Discussion of Race and Medical Ethics
  • IRB Fees: The Cost of IRB Review
  • External and Commercial IRB Q&A – What is the Submission and Review Process for Commercial IRB Applications (WCG/WIRB, Advarra, etc.)?
  • Herky Hints: Linking an External Funding Source in Section III
  • IRB Advisor Newsletter, November 2020
  • In the News

2020

December

  • From the Editor: The Informed Consent Issue, Part 2 (Plus the 10-year Anniversary of the HSRD Form)
  • Happy Holidays from the HSO!
  • FDA Issues Guidance for Enhancing Diversity in Clinical Trial Populations
  • Short Form Document and Process
  • External and Commercial IRB Q&A: How do study teams make/edit an Informed Consent Document for an external commercial IRB?
  • In the News

November

  • From the Editor: The Informed Consent Issue, Part 1
  • Western IRB (WIRB) Online Submission Platform Training, 11/12/20
  • Diversity, Equity and Inclusion in Research/Clinical Trials
  • Creating Informed Consent Documents: Best Practices
  • Exceptions to the Rule: Waivers of Consent (45 CFR 46.116(f)(3))
  • The Consent Summary: A Concise and Focused Description of Key Information
  • Herky Hint: Describing the Consent Process
  • In the News

Late September

  • Invite the Human Subjects Office into Your Classroom for an IRB Overview Presentation
  • The IRB Welcomes New Faculty and Staff Researchers!
  • Conducting a Virtual or Electronic Consent (eConsent) Process for Human Subjects Research
  • Course-Related Student Project Policy and Checklist
  • Getting to Know the Delegate Permission System
  • IRB Advisor, August
  • In the News

Early September

  • Science Thursday with VPR Compliance Units!
  • New CITI Program Course – COVID-19: Back to Campus
  • External and Commercial IRB Q & A: What are the Differences Between Commercial and External Single IRBs?
  • Herky Hint: Closing Time
  • IRB Advisor, June and July
  • In the News

July

  • Two-Step Login Required for Research Administration Services
  • HawkIRB Enhancements & Initiating a Clinical Trials.Gov record on a UI PI’s behalf
  • FDA Updates Clinical Trial Guidance
  • OHRP Updates Decision Charts
  • What Is Not Considered Human Subjects Research?
  • External IRB Q & A: What Terminology Do I Need to Know?
  • Herky Hints: Subject Compensation
  • IRB Advisor, April and May
  • In the News

June

  • From the Director: University of Iowa Human Research Protection Program Achieves Reaccreditation!
  • HawkIRB Application Updates
  • IRB Educational Opportunities Now Available Over Zoom
  • Updated Data Security Guidance
  • Saying Goodbye: Researchers Leaving the UI
  • Resources for Potential Participants
  • IRB Advisor, March 2020

April

  • Changes to the eResearch (HawkIRB) Application
  • Pharmacy and Therapeutics (P&T) Investigational Drug Service (IDS) Upgrades
  • Changes to the VA Privacy Officer and VA Information Security Officer Checklists
  • COVID-19 Related Updates

February

  • From the Director: Removal of Delegates in HawkIRB
  • Getting Started: Do I Need IRB Approval?
  • Informed Consent Document Checklist
  • IRB Advisor, January 2018: Right to Try in Oncology: Gatekeepers or Mercenaries?
  • In the News

January

  • Last of the Revised Common Rule Changes Effective January 20th
  • Annual Disclosure of Outside Activities Due April 30th
  • The IRB is Blooming with Educational Opportunities, Spring 2020
  • Invite the Human Subjects Office into Your Classroom for an IRB Overview Presentation
  • Conducting Research with Prisoners
  • IRB Advisor, December 2019: SACHRP Recommendations on Pay-to-Participate Research
  • In the News

 

2019

December

  • Seasons Greetings from HSO
  • Tracking HCCC Research
  • New Postings on HSO Website
  • HawkIRB Changes: Clarifying NRC Review (Section V.26)
  • IRB Advisor: Is "Informed Consent" an Oxymoron?
  • In the News 

November Regulatory Newsletter

  • National Cancer Institute (NCI) funded research occurring at the Iowa City VAHCS
  • Announcing New Policies Regarding IBC Review
  • Other Committee Review Tool

October Regulatory Newsletter

  • From the Director and IRB Education Outreach Manager
  • What Does It Mean to be AAHRPP Accredited?
  • Investigator Guide Changes – Oct 2019 Regulatory Newsletter
  • New Educational Tool – Data Security
  • Coming Soon! A Change in the Assignment of HawkIRB ID Numbers

May

  • Welcome, New Faculty/Staff Researchers
  • Request a Presentation Now for your Research-Oriented Class or Group
  • Course-Related Student Projects
  • External IRB Review Process
  • Before You Go: PI Transfer/Departure Checklist

 

2018

IRB Regulatory and Policy Updates

  • Changes to the timing of IRB approval and Pharmacy & Therapeutics Investigational Drug Service approval
  • Changes to question V.22 that may impact research submissions
  • New Automated UI Health Care Clinical (UIHC) Trials and Research Website recruitment tool

October

  • Exploratory Workshop- Informed Consent
  • Research Ethics Reading List
  • Biorights: Subjects' Rights in Future Research

August

  • New Faculty/Staff Orientation to the IRB
  • Mass Email for Research Recruitment
  • IRB Member Recruitment: Seeking IRB Community Members
  • Protocol Changes or New Information: Remember to Re-Consent Subjects
  • The Role of Risk Management in Reviewing Human Subjects Research

June

  • Congratulations to Lori Dolan and Dixie Ecklund
  • 2018 Common Rule: Another 6-Month Delay for Compliance
  • Spanish Resources for the Protection of Research Participants
  • Deception Research: Withholding Information from Subjects

April

  • ClinicalTrials.gov Office Hours
  • Conflict of Interest Disclosure Deadline
  • Revised Common Rule Delay
  • Determining Capacity to Consent
  • Data Use Agreements
  • Research in the Early Modern Era
  • Herky Hints: HawkIRB Workflow and You
  • IRB Advisor, April 2018: The Search for Justice in the Human Genome

March

  • ClinicalTrials.gov Registration Tool
  • Hardin Library Exhibit about Human Subjects Research
  • New International Listing of Social/Behavioral Research Standards
  • Using UI Mass Email for Study Recruitment: The Top 5 Things Researchers Should Know
  • Expressing Appreciation and Reporting Concerns
  • Genetics and Research: New Frontiers, New Challenges
  • Herky Hints: How to Get Your HawkIRB Applications Approved Quicker

Regulatory/Policy Update

  • New Policy and Procedures: Documenting Research Participation in the UIHC Medical Record
  • Revised UI Health Care Policy and the Research Billing Compliance Process
  • Training Requirements Associated with the UI Health Care Policy Change

February

  • Updates to Federal Regulations/Guidance
  • HawkIRB Trainings, IRB Presentations, and Office Hours
  • Resources for New Researchers
  • IRB Education
  • HH: HawkIRB Delegate Permission System

2017

December

  • Feedback about IRB Educational Resources
  • Subversive Subjects in Clinical Trials
  • Clinical Trials.gov

November

  • Update to GCP Training Certificates
  • Mail-out Consent
  • Expanding Vulnerable Populations

October

  • ITS Update of Mass Email Policy
  • SBIR/STTR
  • Patient Advocacy Groups in Research
  • External/Commercial IRB Q&A 

September 

  • Summer Article Recap
  • CITI Training
  • PRIM&R: Informed Consent and the Revised Common Rule
  • Resources for Researchers

August

  • FDA Draft Guidance for Electronic Records and Signatures
  • Other Human Research Protection Program Committees & Units
  • Risk Communication and Consent

July

  • Enrolling Children in Research
  • Documentation of Informed Consent- Best Practices
  • International Research
  • Quality Assurance/Quality Improvement
  • External/Commercial IRB Q&A
  • HH: Accessing Medical Records for Recruitment Purposes

May

  • ClinicalTrials.gov Final Rule Updates
  • Changes in the HawkIRB Approval Tab
  • Changing PIs and RTMs in HawkIRB
  • External/Commercial IRB Q&A
  • HH: Funding Source Modifications

March

  • The New HawkIRB Carousel Index
  • External/Commercial IRB Q&A
  • VA/UI Research & Multiple Applications
  • Top Monitoring Findings of 2016

February

  • Feedback and Suggestions
  • IRB Presentations
  • Documenting Subject Agreement for Optional Research Activities

2016

December

  • Looking Back and Looking Forward
  • Ethical Principles Series- Justice
  • Umbrella Projects

November

  • Updates from the Director
  • Multisite Research with sIRB
  • Essentials of Central/External IRB
  • Commercial IRB
  • Navigating sIRB Reliance
  • External IRB Q & A
  • Herky Hints: HawkIRB with UI as Lead OR Relying IRB
  • IRB Advisor November 2016

October

  • Regulatory Updates from the Director
  • Ethical Principles Series -- Beneficence
  • Anonymity in Qualitative Research
  • Reportable Events
  • IRB Advisor Newsletter

September

  • Summer Article Recap
  • IRB Member Recruitment
  • Diversity in Online Research
  • Herky Hints: Contact People
  • Classroom Presentations
  • IRB Advisor Newsletter

August

  • Ethical Principles in Research - Respect for Persons
  • Course-Related Student Project Updates
  • Herky Hints: What to Review for your Continuing Review
  • A Measure of Our Performance: 2015 IRB Review Metrics
  • The IRB Advisor Newsletter, August 2016: NIH Clinical Center Riddled With Research Problems 

July

  • Updates from the Director
  • VII.B.1 Enhancements
  • Clinical Trials.gov registration and reporting
  • Research in Online Environments
  • Research Subject compensation Reminder
  • The IRB Advisor Newsletter, July 2016

June

  • The Central and External IRB Model of Oversight
  • Changes to the Continuing Review reminder
  • The IRB Advisor Newsletter, June 2016

May

  • Updates from the Director
  • Health Literacy and Therapeutic Misconception: Barriers to Informed Consent
  • Using Mobile Technologies to Address Barriers to Participation in Clinical Trials
  • IRB-04 Department of Defense: Announcing the UI’s Newest IRB
  • The IRB Advisor Newsletter, May 2016

March

  • Updates from the Director
  • Sex Bias and Clinical Trial - An Ongoing Concern
  • The IRB Advisor Newsletter: An educational resource
  • Got a Minute to Talk About IRB Meeting Minutes?

February

  • UI’s Institutional Conflict of Interest in Human Subjects Research
  • New FDA Site Inspection Guidance
  • Promises, Promise: I Assure You...What Exactly?
  • Using Social Media for Research Recruitment 

2015

December

  • HawkIRB Phase II Changes: Central and External IRB Models
  • Developing Your Data Management Plan
  • HawkIRB Hints: Breaking Down the Details of Risks

October

  • Changes to the HawkIRB Application: Phase 1
  • Underrepsentation in Clinical Trials: The Black Experience
  • HawkIRB Hints: YOU Can Prevent Reportable Events!

August

  • Back to School Special: Faculty Advisor Responsibilities
  • Attention Biomedical Researchers: New Type of PRMC Notice
  • HawkIRB Hints: Finding Your Way in HawkIRB

June

  • It’s OK to Delegate, but Remember… It’s Still Your Study!
  • How Do I…?  FAQ Page Links
  • HawkIRB Hints: How Do You Attach a Revised Document?

April

  • The Tattletale IRB
  • IRB Compliance Staff to attend FDA Audits
  • HawkIRB Hints: Best Kept Secret

February

  • "I didn't think it was Human Subjects Research because..."
  • UI policy on Mandatory Reporting of Physical and Sexual Abuse of Children: The Research Perspective
  • Conflict of Interest in Research-Implications for Investigators

2014

December

  • External IRBs incorporated into HawkIRB
  • Financial Interest Disclosure Reporting
  • News Flash

October

  • Financial Conflict of Interest in Research
  • Upcoming AAHRPP Site Visit
  • Subjects Who Are Lost to Follow-up
  • News Flash: HSO Interim Director appointment and staff departures

September

  • Keeping Current on International Research Regulations
  • Tips to Improve your Informed Consent Document
  • Mainline Questions: HawkIRB Workflow

August

  • Facebook's Controversial Sociological Study
  • A personal Note from the HSO director
  • Need help with HawkIRB? Herky Hints: Oops, I Made this Draft... Now What?
  • New Positions filled in the Human Subjects Office!

July

  • Research Misconduct, Prevention Strategies and More
  • Changes in IRB Determinations for Studies that Access PHI for Recruitment
  • Did You Know? – HSO Presentations
  • Who Should Be a Research Team Member?
  • Try Your Hand at Being an IRB Chair

June

  • A More Flexible IRB on the Horizon
  • Tips to Protect and Secure Information When Using Mobile Devices
  • News Flash: Relocation of the Conflict of Interest in Research Program
  • Need help with HawkIRB?  Herky Hints: Assurance Document

May

  • IRB Review of Qualitative Research – Just Jumping Through the Hoops?
  • A Change in Your Summer Plans? - Let us Know!
  • News Flash: HSO Staff Farewell
  • Need help with HawkIRB? Herky Hints: Dealing with HawkIRB email notifications

April - Research with Children Special Edition

  • Risk and IRB Review
  • Assent
  • Parental Permission  
  • Applicable Regulatory Definitions
  •  HawkIRB: Procedures for Obtaining Consent and Assent
  • Pregnancy in a Minor Subject Population

April

  • Describing Risk to Research Participants
  • Disclosing the Probability and Magnitude of Physical Risk
  • What We Did Last Month...Submitted an application for AAHRPP Re-Accreditation
  •  News Flash: Changes with HawkIRB and the CRU
  • This month in Human Subjects Protection History: The Belmont Report

March

  • Additional Requirements for DoD Research
  • Where is this CITI of which you speak, and what does it have to do with me?
  • Spring Break Reminder (submit your HawkIRB application/HSRD)
  • IRB Policy Revision: Revised Guidelines Regarding Payment and Compensation
  • What’s that Mean?: Certified IRB Professional

February

  • New Compliance Monitoring Programs Coming to a Study Near You
  • News Flash: HSO New Hours of Operation
  • IRB Policy Revision: Inclusion of Compensation Amount in Recruitment Materials
  • IRB Policy Reminder: Cold-Calling of Potential Subjects as a Recruitment Method

January - Reportable Events Special Edition (IRB-01/03) 
January - Reportable Events Special Edition (IRB-02) 

  • What are Reportable Events?
  • Serious Adverse Drug Events (IRB-01/03)
  •  Serious Adverse Device Effect (IRB-01/03)
  •  Reportable Events Q&A: Why do I need to submit REFs?
  • Receipt of New Information
  • Unanticipated Problems Involving Risks to Subjects or Others
  • Noncompliance
  • Preventing Reportable Events

January

  • Letter from the Editor
  •  Should I Submit a New Project Application or a Modification?
  • News Flash: Andy Bertolatus' retirement announcement
  • Back to School Reminder: Submit your HawkIRB Application

2013

December

  • Why is My Study Going to the Full Board?
  • Come to the Dark Side, we have cookies! (Working for the HSO)
  • What's that Mean?: Human Subjects Research Acronyms
  •  HawkIRB: How Do I Use the Inbox Filter?

November

  • The Informed Consent Process
  • Mainline Questions: Flavors of Waivers
  • Use of Short Form Consent Document for Non-English Speaking Subjects
  • Obtaining Required Signatures on the Informed Consent Document

October

  • Coercion and Undue Influence: What is the difference?
  • Mainline Questions: Alphabet Soup (HSO vs. IRB)
  • HawkIRB: How Do I Use the Delegate Permission System?
  • IRB Policy Reminder: Requirements for Completion of Optional Agreements

September

  • Mainline Questions: What does Exempt mean?
  • The Mailed Consent Process: What to do if there are errors?
  • Back to School: Human subjects research in the classroom
  • News Flash: Course-Related Student Project Policy Revision
  • IRB Policy Reminder: UI Students as Research Subjects

August

  • Enrolling Minors: What Happens When They Age Up?
  • HIPPA/HITECH Act Omnibus Final Rule
  • Human Subjects Research Data and Sample Identification Terms
  • IRB Policy Reminder: Case Report Forms (CRFs) Should not be attached to the HawkIRB Application
  • Have an idea for IRB Connection?

July- Genetic Research Special Edition

  • Federal Regulations and Guidance
  • Genetic Information Nondiscrimination Act (GINA)
  • Is it Genetic Research?
  • Incidental Findings

July

  • Top 5 Monitoring Findings of 2012
  • Mainline Questions: Do I have to fill out an IRB application?
  • HawkIRB: How do I find my Approval Memo?
  • Get to Know: The HSO Exec. Director and UI Institutional Official
  • News Flash: My Research Portal

June

  • Greetings from the HSO: Mainline Questions
  • New FDA Rule: Children in Clinical Investigations
  • IRB Policy: Compensation in Recruitment Materials
  • Get to Know: The Education and Compliance Staff

May

  • Plain Language Facilitating Subjects Understanding
  • Revisions to the Declaration of Helsinki
  • IRB Policy Reminder: Recording Additional Information on the Informed Consent Document
  • Issues to Consider when a PI leaves the UI
  • Get to Know: The IRB-02 Staff